(Cost-)Effectiveness of SLIMMER Diabetes Prevention Intervention

Not Applicable

• Conditions: Diabetes Mellitus Type 2
• Interventions: Behavioral: Combined lifestyle intervention; Other: Usual care group

• Registration Number: NCT02094911
• Lead Sponsor: Wageningen University

Brief Summary

The overall aim of the project is to evaluate the (cost-)effectiveness of the SLIMMER diabetes prevention intervention in Dutch primary health care.

Detailed Description

This is a randomised controlled trial, conducted in a real-life setting (Dutch primary health care).

Study Timeline

• Study Start: 2011-10
• Status Verified: 2014-03
• Study First Submitted: 2014-03-19
• Study First Submitted QC: 2014-03-19
• Last Update Submitted: 2014-03-19
• Study First Posted: 2014-03-24
• Last Update Posted: 2014-03-24
• Primary Completion: 2014-05
• Study Completion: 2015-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 316

Inclusion Criteria

• Age 40-70 years

• Impaired fasting glucose (IFG; i.e. venous plasma glucose concentration ≥6.1 and

  ≤6.9 mmol/l) during the past 5 years, according to the GP registration database OR diabetes risk score ≥7 as calculated from the Diabetes Risk Test

• Willing and able to participate in the intervention for at least 1.5 years

• Dutch speaking

Exclusion Criteria

• Known diabetes mellitus

• Any chronic illness that makes 1.5-years survival improbable, interferes with glucose tolerance, or makes participation in a lifestyle intervention impossible

• Patients with any severe cardiovascular disease (this also includes history of cardiac dysrhythmia), unless GP gives agreement

• Medication known to interfere with glucose tolerance

• Any mental or physical disability that will hinder participation in the lifestyle intervention

• Severe psychiatric disease

• Patients who showed bad compliance in the past

• Participation in another regular vigorous exercise and/or diet programme, i.e.:

  • Intensive exercise programme: any exercise programme offered by a physiotherapist and/or patients sporting at least 3 times a week at their own initiative.
  • Intensive diet programme: patients who visited a dietician at least 3 times during the last year.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combined lifestyle intervention	Combined lifestyle intervention	Lifestyle counselling (nutrition and physical activity) by dietician and physiotherapist during 10-month intervention period
Usual care group	Usual care group	Subjects receive brochures on healthy lifestyle at baseline, and during the 10-month intervention period only usual care as provided by their own general practitioner.

Primary Outcome Measures

Name	Time	Method
Change in fasting insulin	Baseline, end of intervention (12 months), after follow-up (18 months)

Secondary Outcome Measures

Name	Time	Method
Glucose tolerance	Baseline, end of intervention (12 months), after follow-up (18 months)	fasting glucose, 2h glucose, 2h insulin, HbA1c
Serum lipids	Baseline, end of intervention (12 months), after follow-up (18 months)	total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides
Physical fitness	Baseline, end of intervention (12 months), after follow-up (18 months)	measured with six-minute walk test
Blood pressure	Baseline, end of intervention (12 months), after follow-up (18 months)
Medication use	Baseline, end of intervention (12 months), after follow-up (18 months)
Quality of Life	Baseline, end of intervention (12 months), after follow-up (18 months)
Eating behaviour	Baseline, end of intervention (12 months), after follow-up (18 months)	Measured as nutrient intake and food intake, with a Food Frequency Questionnaire
Physical activity behaviour	Baseline, end of intervention (12 months), after follow-up (18 months)	Measured with questionnaire
Behavioural determinants	Baseline, end of intervention (12 months), after follow-up (18 months)	Determinants of nutrition and physical activity behaviour, measured with questionnaire
Body fatness	Baseline, end of intervention (12 months), after follow-up (18 months)	body weight, BMI, waist and hip circumference, body fat
Process indicators	Baseline, end of intervention (12 months), after follow-up (18 months)	Indicators to investigate how the intervention was delivered and received, measured with quantitative and qualitative methods

Trial Locations

Locations (1)

Wageningen University; 🇳🇱 Wageningen, Netherlands